Europe – MDCG 2022-4 Rev 2 Guidance on appropriate surveillance regarding the transitional provisions...
Article 120 of the Medical Device Regulation (EU) 2017/745 (MDR), as amended by Regulation (EU) 2023/6071, states that devices which are covered by valid...
UK – MHRA announces consultation on improved safety for high risk in vitro diagnostic...
IVD devices are used to examine samples taken from the human body and to diagnose and monitor health conditions. For example, devices can determine...
UK – Home testing devices could increase the number of people diagnosed with sleep...
An independent NICE committee has recommended five devices to diagnose and assess the severity of obstructive sleep apnoea hypopnoea syndrome (OSAHS).
Around five per cent...
UK – MHRA announces a proposed framework for international recognition of medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (21 May 2024) published a statement of policy intent for international recognition of medical devices.
The MHRA’s...
Europe – EMA revises Q&A guidance on drug-device combination products
The European Medicines Agency and the Co-ordination Group for Mutual Recognition and Decentralized Procedures (CMDh) have issued a revised guidance that clarifies the information...
Europe – Notified bodies concerned with lack of MDR/IVDR applications as deadlines approach
Notified body (NB) capacity has risen significantly in recent years as the number of designations has increased; however, some manufacturers have yet to transition...
Europe – Medical devices: new guidance for industry and notified bodies
A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices has been published today. This question-and-answer document provides practical considerations on the...
UK – EM on EU regulations 2017/745 & 2017/746 (COM(2024)43)
This explanatory memorandum is about a European Commission for a proposal for a regulation of the European Parliament and of the Council amending regulations (EU)...
Europe – EU report examines barriers to combined studies of drugs, IVDs, and devices
A lack of alignment between the Clinical Trials Regulation (CTR) the In Vitro Diagnostic Medical Device Regulation (IVDR), and the Medical Device Regulations (MDR)...
UK – MHRA’s AI Airlock to address challenges for regulating AI medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, a new regulatory sandbox, to address the challenges of regulating medical devices...
